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The Health Information and Quality Authority ("HIQA") have published an independent report on the implementation of non-approved medical devices into children suffering with scoliosis at Temple Street Children’s Hospital. The report revealed that between 2020 and 2022, non-approved metal springs were implanted into three children who had undergone surgery to treat scoliosis.
Background
In early August 2023, Children’s Hospital Ireland (“CHI”) issued a report outlining findings and recommendations from two formal reviews – both internal and external – which were conducted on Spina Bifida patients at Temple Street.
The report highlighted many serious issues and failings in respect of the quality of spinal surgeries and patient care in Temple Street. The families of affected patients and advocacy groups said that the report was not wholly transparent, and they subsequently called for the commission of a detailed external review and government intervention.
In November 2023, the HIQA were tasked by the then Minister for Health, Mr Stephen Donnelly, with carrying out an independent review.
HIQA Report Findings
The report found that the surgeon responsible for the implementation of the springs, described in the report as ‘Surgeon A’, opted to use the springs as a supplement to "well-established and completely separate conventional growing-rod system" after attending a presentation at an international orthopaedic conference by a team of researchers from the Netherlands. The team of researchers informed the HIQA they had not been contacted by Surgeon A or anyone at CHI Temple Street to discuss their research.
Furthermore, the report found there was "significant deviation" from CHI Temple Street’s "decontamination" policy insofar as each individual spring was not given a unique identifying number that would allow for proper tracking of each, meaning no one could account for the origin or past use of the springs used in the procedures.
Administrative Failures
The report also revealed a host of issues in the governance of CHI Temple Street and CHI in general, including but not limited to:
A lack of overarching CHI-wide standardised governance structures and supporting policies and procedures in place for the introduction and use of medical devices.
Differences in the procurement process between each hospital site.
No standardised processes in place across CHI in relation to the governance for the introduction and use of medical devices in practice.
An unnecessarily complex management structure within CHI that created uncertainty and eventually led to "a misalignment of governance and reporting lines as it related to the introduction and use of medical devices at CHI Temple Street".
Conclusion
While the incorrect implementation of the springs can be ascribed to an individual lapse in judgment, as noted by An Taoiseach, Mícheal Martin, in his remarks to the Dáil on 8 April 2025, the HIQA report makes clear that such an error was fostered by deep institutional failures with the CHI structure.
The report has acknowledged CHI’s work to address these failures since the investigation began, but it remains to be seen whether these changes will sufficiently improve its processes and governance to prevent similar incidents occurring going forward.
Further Information
For further details, please see our prior Temple Street articles examining the controversy:
External Medical Review for Spina Bifida Patients at Temple Street Hospital
Temple Street Spinal Surgeries Controversy: Recent Developments
Expert Guidance
Lavelle Partners are currently advising a number of clients on this matter.
For expert legal advice or guidance if you have been affected by these developments, please contact Avril Scally (Partner) or Avril Carroll (Solicitor) in our award-winning Medical Negligence & Personal Injury Team.
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